3 doses, 21 hours

IV Acetadote is

  • FDA-Approved IV N-Acetylcysteine
  • The only EDTA-free N-Acetylcysteine formulation

IV Acetadote may be the right choice for:

  • Patients presenting with significant nausea and vomiting, a symptom of acetaminophen overdose
  • Patients who are unconscious
  • Patients who cannot tolerate oral medication

For maximal protection against hepatic injury administer IV Acetadote within 8 hours post-ingestion.

CONTRAINDICATIONS

Patients with previous anaphylactoid reaction to acetylcysteine.

WARNINGS AND PRECAUTIONS

  • Acute flushing and erythema of the skin and serious anaphylactoid reactions may occur
  • Use with caution in patients with asthma or history of bronchospasm
  • Adjust total volume for patients less than 40 kg and for those requiring fluid restriction

Acetadote should be used with caution in patients with asthma or where there is a history of bronchospasm.

About Acetaminophen Overdose

Based on data from the American Association of Poison Control Centers (AAPCC), acetaminophen was involved in more than 187,000 poisoning exposures in the United States in 2009, including more than 100,000 cases of acetaminophen in combination with other medications. About 46,000 exposures were treated in healthcare facilities.1 Of those treated approximately 26,000 received N-acetylcysteine.

About Acetadote

The only FDA-approved IV acetylcysteine for acetaminophen overdose.

Acetadote, introduced in the United States in 2004 and currently used in more than 3,000 hospitals across the U.S., is a safe and efficacious treatment for acetaminophen overdose when administered within 8-10 hours post-ingestion. With a 3-dose, 21-hour IV N-acetylcysteine infusion, Acetadote is the shortest FDA-approved treatment regimen for acetaminophen overdose.


Indication

Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury.

For maximal protection against hepatic injury, administer Acetadote within 8 hours post-ingestion.

Efficacy diminishes progressively after 8 hours and treatment initiation between 15 and 24 hours post-ingestion of acetaminophen yields limited efficacy.

Important Safety Information

Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered acetylcysteine intravenously.

Acetadote should be used with caution in patients with asthma, or where there is a history of bronchospasm. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure, and death.

In the literature, the most frequently reported adverse reactions attributed to IV acetylcysteine administration were rash, urticaria and pruritus. The frequency of adverse reactions has been reported to be between 0.2% and 20.8%, and they most commonly occur during the initial loading dose of acetylcysteine.

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References

  1. Bronstein AC, Spyker DA, Cantilena JR, et al. 2009 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 27th Annual Report. Clin Tox 2010; 48:979-1178.